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Clinical Trial Summary

Background: Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication. Study design: Retrospective study. All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03054012
Study type Observational
Source AZ Sint-Jan AV
Contact
Status Completed
Phase
Start date October 2016
Completion date February 2017

See also
  Status Clinical Trial Phase
Terminated NCT01834339 - EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection Phase 2
Recruiting NCT03678467 - Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction Phase 1/Phase 2
Completed NCT00628849 - Champy Versus AO for Mandible Fractures N/A